Methods of securing a cardiac implant using knotless suture clamps

ABSTRACT

Suture locking clamps for securing prostheses such as heart valves or annuloplasty rings with sutures and without using knots improve the ease of implantation. The clamps have opposed clamp halves separated by a slot opening to one side and surrounded by a biasing member such as one or more C-clip springs. Sutures pass laterally into the slot which is held open by a retention member positioned between the clamp halves. The locking clamp slides along the sutures into position, the tension of the sutures is adjusted, and the retention member removed to allow the biasing member to clamp the sutures between the clamp halves. A delivery tool used to deliver and deploy the locking clamps contains a number of clamps within a delivery tube in a stack and bonded together for safety and a common retention member. The tool has a longitudinal channel on one side for entry of sutures.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.15/944,337 filed Apr. 3, 2018, now U.S. Pat. No. 10,631,854, which is acontinuation of U.S. application Ser. No. 15/362,529, filed Nov. 28,2016, now U.S. Pat. No. 9,936,947, which is a continuation of U.S.application Ser. No. 14/797,112 filed Jul. 11, 2015, now U.S. Pat. No.9,504,466, which is a continuation of U.S. application Ser. No.13/920,983, filed Jun. 18, 2013, now U.S. Pat. No. 9,078,652, which is acontinuation-in-part of U.S. application Ser. No. 13/719,009, filed Dec.18, 2012, now U.S. Pat. No. 9,078,645, which claims the benefit of U.S.Application No. 61/639,759, filed Apr. 27, 2012, and of U.S. ApplicationNo. 61/577,255, filed Dec. 19, 2011, the entire disclosures all of whichare incorporated by reference for all purposes.

FIELD OF THE INVENTION

The present invention relates to devices and methods for securingprosthetic implants to soft tissue and, more particularly, to sutureclamps and methods for anchoring prostheses inside or near the heartusing sutures without knots.

BACKGROUND OF THE INVENTION

Sutures are used for a variety of surgical purposes, such asapproximation of tissue and ligation of tissue. When placing sutures,the strand of suture material to be used typically has a needle affixedto one end which is passed (looped) through the tissue to beapproximated or ligated, forming a stitch. The stitch is then tensionedappropriately, and the two free ends of the suture loop, the needle endand the non-needle end, are knotted to retain the desired tension in thestitch. Forming knots in suture during open surgery is a simple matter,though time-consuming, but forming knots in sutures during endoscopicsurgery can require two surgeons to cooperate in a multi-step processwhich is performed with multiple instruments to pass the needle andsuture back and forth to tie the suture knot.

Within the prior art there exists a need for devices and methods thatreduce the time required to secure a heart valve repair prosthesis inplace. To repair or replace a defective valve, clinicians can performtraditional open heart surgery or can utilize a minimally invasive ortranscatheter technique. Traditional open heart surgery involvesadministering anesthesia and putting a patient on cardio-pulmonarybypass. A clinician cuts open the chest to access the heart, and thentypically excises the defective native valve leaflets leaving theannulus in place. The clinician places sutures in the annulus or othertissue near the heart valve, and threads the free ends of each loop ofthe sutures through a sewing cuff on the heart valve prosthesis. Theheart valve is then “parachuted” into place by sliding it down thesuture free ends until it rests on the annulus. The free ends of eachsuture loop are tied together on the proximal side of the heart valvewith multiple knots to prevent the sutures from backing out. Normally,this process entails about 5-10 knots on each of the 12-20 sutures usedper implant, which lengthens the time a patient is on cardio-pulmonarybypass and under anesthesia. There is a direct correlation between timespent on bypass and poor outcomes, and thus any reduction in surgicaltime that a patient undergoes would be beneficial. Implantation of anannuloplasty ring follows a similar procedure except that the nativevalve is typically left in place. The annuloplasty ring is sutured inplace to reshape or repair the valve annulus and improve native heartvalve leaflet coaptation.

There also exists a need to make it easier to secure a heart valverepair prosthesis in place. Currently, a clinician must work in thelimited space near the heart to tie knots in sutures. This is acumbersome process that benefits from a clinician of great dexterity andpatience. In a minimally invasive surgery the clinician must use toolsthat can be passed through a small incision, thus making the tying ofknots even more difficult. To implant the prosthesis, a clinician makesa small incision in the chest and uses special tools to pass the heartvalve repair prosthesis through the incision. An example of a minimallyinvasive heart valve repair procedure is transapical aortic valvereplacement.

Suture locking clamps that eliminate the need to tie knots in order tospeed up heart valve replacement are known, as are suture lockingdevices in general. Suture retainers or locks are used in place ofsuture knots to prevent passage of a suture end into and through tissueand to maintain the tension applied to the suture material during thesuturing procedure. Suture clips and other suture retainers aredescribed in the following publications: U.S. Pat. Nos. 6,066,160,6,475,230, 7,862,584, 7,875,056, 8,100,923, and 8,105,355.

Despite the existence of knotless suture locking clamps in the art,there is a need for improved clamps that enable accurate tensioning ofthe suture and are simple to use. Some of the prior clamps utilize awedge-type system in which a wedge or opposed wedge surfaces are broughttogether to clamp on the suture. Some of these clamps are susceptible tochanges in the magnitude of tension in the suture as they are beinglocked, either loosening or tightening the suture, while others may workloose if there is no additional mechanism to hold them in place. Somedevices such as U.S. Pat. No. 7,862,584 utilize a clamping system havinga tortuous path for the suture, which are difficult to thread and alsomay work loose. Another type of suture locking device shown in U.S. Pat.No. 7,235,086 makes use of a plastically deformable member to capturethe suture therein. This device depends on accurate deformation of theclamping member, which might permit the suture to slip loose ifinsufficiently deformed.

SUMMARY OF THE INVENTION

The present invention provides an improved suture locking clamp forsecuring heart valve repair or replacement prostheses in or near theheart. The apparatus and methods are particularly well suited fortraditional surgery or minimally invasive surgery. The clamps disclosedherein eliminate the need for surgical knots thus reducing surgical timeand exposure. Further, the clamps improve the ease of implantationbecause the clinician need not tie knots in the limited space in andaround the heart. Finally, the suture locking clamps are simple toinstall and their actuation does not affect suture tension.

In accordance with one preferred aspect, the present application providea system for locking a device on one or more sutures, comprising one ormore sutures each having a thickness, a bifurcated clamp member, abiasing member positioned on the outside of the locking clamp, and aretention member positioned between the clamp halves. The locking clampincludes a pair of substantially similar clamp halves each having anexterior surface and an inner surface facing the inner surface of theother clamp half to form a variable-sized side-opening slottherebetween. The clamp halves are connected for movement toward or awayfrom one another while being fixed axially with respect to one another,wherein the suture(s) extend through the slot between the inner surfacesof the clamp halves. The biasing member has a relaxed size that, in theabsence of an object in the slot, urges the inner surfaces of the clamphalves together such that the slot has a width smaller than the suturethickness. The retention member acts against the force of the biasingmember and has a thickness that maintains the slot width large enough topermit passage of the suture(s) therethrough, wherein removal of theretention member permits the biasing member to urge the inner surfacesof the clamp halves together and clamp the suture(s) therebetween.

The clamp halves may be separate elements, and they may be separate andhinged together or one piece with a living hinge therebetween. The innersurfaces of the clamp halves may include a suture channel size toreceive each suture. In one embodiment, the clamp halves each includes acutout facing a similar cutout of the other, the cutouts togetherdefining a retention member channel for receiving the retention member.The retention member may comprise a retention pin having a head and ashaft, or it may be a bifurcated retention clip. The bifurcatedretention clip may have a pair of prongs having parallel free ends thatextent between the clamp halves and angled portions connecting the freeends to a bridge connecting the prongs, the bridge thus being offsetfrom the slot between the clamp halves.

In a preferred embodiment, the clamp halves further include outwardflanges on opposite axial ends that retain the biasing member inposition around the locking clamp. The biasing member may be a coilspring, and the exterior surface of the clamp halves is at least partlycylindrical such that the coil spring provides a substantially uniforminward radial compressive force on the device. Alternatively, the clamphalves are hinged together on a first circumferential side defining avariable-sized side-opening slot on the side opposite the firstcircumferential side, and wherein the biasing member comprises aplurality of C-clips arranged around the locking clamp with their freeends located on either side of the variable sized slot opposite thefirst circumferential side. In one such embodiment the clamp halves aremolded from a single piece of material with a living hinge on the firstcircumferential side. In a preferred version the inner surfaces of theclamp halves possess features to enhance friction between the clamphalves and the suture, and more preferably the inner surfaces of theclamp halves possess features to create one-way friction between theclamp halves and the suture(s). A maximum radial dimension of thebifurcated clamp member is desirably about 2 mm or less.

The devices are particularly well suited for traditional surgery orminimally invasive surgery, and improve the ease of implantation byeliminating surgical knots a clinician would normally tie in the limitedspace in and around the implant site. In one version, the devices haveopposed clamp halves surrounded by a coil spring. Sutures pass betweenthe clamp halves and the coil spring has an inner coil diametersufficient to compress the sutures between the clamp halves. A retentionmember positioned between the clamp halves maintains a minimum space andtherebetween to enable the locking device to be slid along the suturesinto position, and to adjust the tension of the sutures therethrough. Adelivery tool may be used to deliver and deploy the locking devices.

One aspect of the present application is a system for locking a clamponto at least one suture having a thickness. The system includes anelongated delivery tool having a delivery tube with a proximal end, adistal end, and a lumen therein, an elongated retention member thatextends along the delivery tube, and an actuation trigger on a proximalend of the tool that causes axial displacement of the retention member.A plurality of suture locking clamps are arranged axially in a stackwithin the delivery tube, each having a bifurcated clamp memberincluding a pair of substantially similar clamp halves with an exteriorsurface and an inner surface facing the inner surface of the other clamphalf. The clamp halves are fixed axially with respect to one anotherwhile being connected for movement toward or away from one another toform a variable-sized side-opening slot therebetween perpendicular tothe axis sized to receive a suture. Each clamp further includes abiasing member that, in the absence of an object in the slot, urges theinner surfaces of the clamp halves together such that the slot has awidth smaller than the suture to clamp onto the suture. The deliverytool retention member is positioned between the clamp halves of eachlocking clamp against the force of the respective biasing member tomaintain the slot width large enough to permit passage of a suturetherethrough. Removal of the retention member permits the biasing memberto urge the inner surfaces of the clamp halves together and clamp thesuture(s) therebetween, and the retention member may be retracted frombetween the clamp halves of just the distal most clamp to deploy thedistal clamp onto the suture. The delivery tube may also have alongitudinal channel commencing at a distal tip and extending a distanceaxially along the tube, the stack of suture locking clamps beingoriented so that their side-opening slots are all aligned with thelongitudinal channel to permit side entry of a suture into one or moreof the slots.

Or, a single suture locking device is positioned on the distal end ofthe delivery tool, wherein a distal end of the elongated tension memberengages the retention member to enable tension in the tension member toapply a proximal force to the retention member. Finally, an actuator onthe proximal end of the delivery tool causes relative axial displacementbetween the retention member and the suture locking device so as toremove the retention member from within the variable sized slot andpermit the clamp halves to clamp the suture therebetween.

In one embodiment, the elongated tension member and retention member area single element defining a retention cable extending through multiplesuture locking devices arranged in series within the delivery tube.Further, the actuator on the proximal end of the delivery tool desirablycauses proximal displacement of the retention cable relative to theseries of suture locking devices. Moreover, the system may have a pushertube located within the delivery tube and in contact with a proximalsuture locking device in the series of suture locking devices, whereinthe actuator alternately causes distal displacement of both the pushertube and the retention cable, and then proximal displacement of theretention cable relative to the series of suture locking devices and tothe pusher tube.

In one version of the system, the clamp halves are hinged together on afirst circumferential side such that the variable sized slot defines avariable sized opening on the side opposite the first circumferentialside, and the biasing member comprises a plurality of C-clips arrangedaround the locking clamp with their free ends located on either side ofthe variable sized slot opposite the first circumferential side. If theclamp halves are hinged together, the delivery tube may have alongitudinal channel commencing at a distal tip and extending a distanceaxially along the tube, the series of suture locking devices beingoriented so that their variable sized slots are all aligned with thelongitudinal channel to permit side entry of a suture into one or moreof the slots.

Alternatively, the biasing member comprises a coil spring, and theexterior surface of the clamp halves is at least partly cylindrical suchthat the coil spring provides a substantially uniform inward radialcompressive force on the device. The system may further include a suturesnare that passes from the proximal end to the distal end of thedelivery tool and having a capture loop on a distal end. The captureloop extends from the lumen of the delivery tube through the variablesized slot of the suture locking device and is compressible to enable itto be pulled proximally through the slot. Another possibility is atensioning assembly affixed to the proximal end of the delivery toolhaving an anchor for temporarily securing a suture that extends throughthe delivery tool and through the suture locking device. The tensioningassembly thus enables adjustment of the tension in the suture whensecured to an implant location beyond the distal end of the deliverytool and suture locking device.

The present application also discloses a method for anchoring an implantto soft tissue, the implant having been advanced to the soft tissue downa plurality of loops of suture that are preinstalled at the soft tissue.The method involves first providing an elongated delivery tool having aproximal end and distal delivery tube, the tool further including anelongated tension member that extends along the delivery tube and thatmay be displaced axially from the proximal end. Two free ends of one ofthe suture loops are threaded through a suture locking device, thedevice having a bifurcated locking clamp including a pair ofsubstantially similar clamp halves each having an exterior surface andan inner surface facing the inner surface of the other clamp half. Theclamp halves are fixed axially with respect to one another while beingconnected for movement toward or away from one another to form avariable sized slot therebetween. The free ends extend through the slotbetween the inner surfaces of the clamp halves. The device furtherincludes a biasing member that, in the absence of any other object inthe slot, urges the inner surfaces of the clamp halves together suchthat the slot has a width smaller than the suture thickness. A retentionmember positioned between the clamp halves against the force of thebiasing member has a thickness that maintains the slot width largeenough to permit passage of the suture free ends therethrough, whereinremoval of the retention member permits the biasing member to urge theinner surfaces of the clamp halves together and clamp the suture(s)therebetween. The method includes the steps of:

assembling the suture locking device with a distal end of the deliverytube by engaging a distal end of the elongated tension member with theretention member;

advancing the suture locking device on the distal end of the deliverytube down the free ends of the suture loop until the locking devicecontacts the implant;

adjusting tension in the free ends of the suture; and

displacing the elongated tension member, proximally pulling theretention member from between the clamp halves, thus enabling thebiasing member to force the clamp halves toward each suture and clampthe free ends therebetween.

Another exemplary system for locking a clamp onto at least one suturehaving a thickness features an elongated delivery tool having a deliverytube with a proximal end, a distal end, and a lumen therein, anelongated retention member that extends along the delivery tube. Anactuation trigger on a proximal end of the tool causes axialdisplacement of the retention member. The delivery tube also has alongitudinal channel commencing at a distal tip and extending a distanceaxially along the tube. A plurality of suture locking clamps arearranged axially and bonded together in a stack within the deliverytube, adjacent clamps having a weak point of connection therebetween.Each clamp has a variable-sized side-opening slot perpendicular to theaxis sized to receive a suture and inner clamping surfaces within theslot to clamp onto a suture. The stack of suture locking clamps areoriented so that their side-opening slots are all aligned with thelongitudinal channel to permit side entry of a suture into one or moreof the slots. Proximal displacement of the delivery tool retentionmember deploys at least a distal clamp to clamp the suture(s)therebetween, and the weak point enables easy separation of a deployedclamp from the stack.

In either exemplary system described above, wherein the elongatedretention member may comprise a retention cable. The delivery tool mayfurther include a pusher tube located within the delivery tube and incontact with a proximal suture locking clamp in the stack of suturelocking clamps. The actuator alternately causes first proximaldisplacement of the retention member relative to the stack of suturelocking clamps and to the pusher tube to activate the distal clamp, andthen distal displacement of both the pusher tube and the retentionmember to eject the distal clamp. Alternatively, the sequence could befirst distal displacement of both the pusher tube and the retentionmember, and then proximal displacement of the retention cable relativeto the stack of suture locking clamps and to the pusher tube.Additionally, the delivery tube may be formed of a manually malleablematerial to enable bending by a surgeon, and the retention member isflexible to avoid impeding bending of the delivery tube.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be explained and other advantages and featureswill appear with reference to the accompanying schematic drawingswherein:

FIG. 1 is a drawing of a prosthetic heart valve implanted in the aorticvalve position of a human heart;

FIG. 2 is an enlarged view of the implanted heart valve of FIG. 1;

FIG. 3 is a drawing of an intermediate step in the implantationprocedure of the heart valve shown in FIG. 1;

FIG. 4 is a perspective view of an exemplary suture locking devicedisclosed herein including a bifurcated locking clamp biased together byan exterior coil spring;

FIG. 5A is a longitudinal sectional view through the device shown inFIG. 4 with a retention pin in place, while FIG. 5B shows actuation ofthe device upon removal of the retention pin from a locking clamp tosecure a suture therein;

FIG. 6A is a perspective view of a diametrically hinged locking clampsimilar to that used in the device of FIG. 4, while FIG. 6B is alongitudinal sectional view of the locking clamp;

FIG. 7 is a perspective view of an alternative locking clamp having anaxial hinge;

FIG. 8 is a perspective view of an alternative suture locking device ofthe present application;

FIGS. 9A and 9B are perspective views of a still further alternativesuture locking device shown, respectively, in assembled and lockedmodes;

FIG. 10 is a perspective view of an exemplary tool for delivering anddeploying the suture locking devices disclosed herein;

FIG. 11 is an enlarged perspective view of a distal end of the tool ofFIG. 10 engaging the suture locking device of FIG. 9A;

FIG. 12 is a longitudinal sectional view through the suture lockingdevice of FIG. 8 illustrating enhanced frictional features therein;

FIG. 13 is a view of an inner surface of one of the locking clamp halvesof the device of FIG. 8;

FIGS. 14 and 15 illustrate steps in an exemplary heart valveimplantation procedure utilizing the suture locking devices describedherein and a preferred implantation tool;

FIGS. 16A-16H illustrate a number of steps in an exemplary heart valveimplantation procedure that utilizes a plurality of automated deliverytubes for securing suture locking devices as disclosed herein on aproximal side of the heart valve sewing ring, namely:

FIG. 16A shows a preliminary step in preparing an aortic annulus forreceiving the heart valve including installation of guide sutures;

FIG. 16B shows a hybrid heart valve mounted on a distal section of adelivery handle advancing into position within the aortic annulus alongthe guide sutures;

FIG. 16C shows the hybrid heart valve in phantom in a desired implantposition and alignment of one of a plurality of an automated deliverytubes used to install suture locking devices of the present application;

FIG. 16D shows a step in threading a pair of guide sutures through thedelivery tube and through a suture locking device held thereby;

FIG. 16E shows advancement of the plurality of delivery tubes toward thehybrid heart valve until the suture locking devices abut the sewing ringthereon;

FIG. 16F shows forceps bending outward upper ends of the delivery tubesto improve access to the heart valve and implant site;

FIG. 16G shows a cloth-covered anchoring skirt on the hybrid heart valveexpanded against the subvalvular wall and subsequent removal of thedelivery system, as well as actuation of the delivery tubes to clamp thesuture locking devices onto the guide sutures;

FIG. 16H shows detachment of the delivery tubes from the suture lockingdevices and removal of the tubes;

FIGS. 17A and 17B are longitudinal sectional and enlarged views of theautomated delivery tube used in the procedure illustrated in FIGS.16A-16H;

FIGS. 18 and 19 are longitudinal sectional views of alternativemechanisms for temporarily tensioning sutures to the automated deliverytubes disclosed herein;

FIGS. 20A and 20B are perspective views of an alternative “side entry”suture locking clamp having a bifurcated clamp member with an axialhinge, as in FIG. 7, and biased together by exterior C-springs;

FIG. 21 shows just the bifurcated clamp member, while FIG. 22 shows aninner wall structure of one half of the clamp member and FIG. 23 showsone of the C-springs;

FIGS. 24A-24D are perspective views of a sequence of operation of theside entry suture locking clamp;

FIG. 25 is a perspective cross sectional view of the side entry suturelocking clamp engaging a suture that is pre-attached at one end to theclamp, and showing how the suture(s) can be tensioned further;

FIGS. 26A-26C are perspective views of an exemplary delivery system forthe side entry suture locking clamps described herein;

FIG. 27 is an exploded perspective view of components of the side entrysuture locking clamp delivery system;

FIG. 27A is an enlarged perspective view of a proximal end of one of theside entry suture locking clamps, while FIG. 27B shows a series of theclamps from a distal end as would be loaded into the delivery system;

FIGS. 28A and 28B are longitudinal sectional views through a distal endof the side entry suture locking clamp delivery system;

FIG. 29 is a side view of a series of the side entry suture lockingclamps bonded together;

FIG. 30 is a perspective view of the distal end of a delivery systemshowing one method of separating a deployed clamp from the stack ofclamps; and

FIGS. 31A-31D are schematic views showing steps in use of the deliverysystem to deploy one of the side entry suture locking clamps during aprosthetic heart valve implantation procedure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Various suture locking clamps of the present invention comprise heartvalve repair or replacement prosthesis anchors that improve ease ofimplantation, reduce surgical exposure, and improve prosthesisattachment. It should be appreciated that the principles and aspects ofthe embodiments disclosed and discussed are also applicable to othertypes of surgical procedures, namely annuloplasty ring implant for heartvalve repair. Furthermore, certain embodiments may also be used inconjunction with other medical devices or other procedures notexplicitly disclosed. However, the manner of adapting the embodimentsdescribed to various other devices and functionalities will becomeapparent to those of skill in the art in view of the description thatfollows.

A schematic drawing of a surgical prosthetic heart valve implanted inthe heart 1 by traditional methods is shown in FIG. 1. The left atrium 2and the left ventricle 3 are shown separated by the mitral valve 6. Theaortic valve 7 is at the outflow end of the left ventricle 3. On theopposite side of the heart, the right atrium 5 and the right ventricle 4are shown separated by the tricuspid valve 8. The pulmonary valve 9 isat the outflow end of the right ventricle 4. An exemplary surgicalprosthetic heart valve 10 is shown implanted in the aortic valve 7position. An enlarged view of the aortic valve 7 is shown in FIG. 2. Theaortic annulus 11 is a fibrous ring extending inward as a ledge into theflow orifice, and can be seen with the prosthetic heart valve 10 suturedin place above it. Prior to valve replacement, the native leafletsextend inward from the annulus 11 and coapt or meet in the flow orificeto permit flow in the outflow direction (up in FIG. 2) and preventbackflow or regurgitation toward the inflow direction (down in FIG. 2).

FIG. 3 shows one step of the traditional procedure to implant theprosthetic heart valve 10. During implantation, a clinician pre-installssutures 12 through the annulus 11 of the aortic valve 7. While the heartvalve is held on a fixture or holder 14, a clinician can thread thesuture 12 free ends through a sewing ring 13 on the prosthetic heartvalve 10. Thus, both free ends of each suture 12 extend out of adjacentportions of the sewing ring 13. The valve 10 is then “parachuted” downthe array of sutures 12 in the direction shown and pulls the sutures 12tight so that a seal is formed between the sewing ring 13 and the aorticannulus 11. Next, the clinician ties each suture 12 free end to anotherfree end (typically a loop of one suture strand) securing the prostheticheart valve 10 in place. Normally this process entails about 5-10 knotsper suture and 12-20 sutures are used per implant. The ends of eachsuture 12 are clipped leaving a suture tail comprised of the suture usedto create each knot.

Turning now to the present invention, certain efficiencies when usingthe suture locking clamps described herein which reduce the proceduretime will be explained. In the description that follows, the aorticannulus is used as the implantation site to illustrate the embodiments.The teachings of this invention can also be applied to the mitral,pulmonary, and tricuspid valves; or indeed, other valves in the body,including venous valves. Likewise, unless there is some reason such asspace limitations, the suture locking clamps defined herein could beutilized in other surgical contexts.

A suture locking device 20 according to one embodiment of the presentinvention is shown in FIG. 4. The device 20 comprises a bifurcatedlocking clamp 22, a retention pin 24, and an exterior coil spring 26.Two lengths of sutures 30 a, 30 b are shown passing longitudinallythrough the interior of the device 20. Typically, the two lengths ofsuture 30 a, 30 b comprise the free ends of a suture loop that has beenpre-installed through soft tissue such as a heart valve annulus andpassed through a heart valve sewing ring. In that configuration, thelower two suture fragments illustrated continue downward and connect ina loop, while the upper two fragments continue upward and outside of thesurgical implantation site, such as through a sewing ring of a heartvalve. For purposes of orientation, the upward direction in FIG. 4 shallbe termed the proximal direction, while the downward direction shall bethe distal direction, corresponding to the typical nomenclature used fora heart valve implantation procedure. Of course, proximal and distal arerelative terms that refer to the position of the surgeon relative to theimplant site, and these could be reversed depending on the particularprocedure.

In any event, the suture locking device 20 defines a central axistherethrough along the proximal-distal orientation. FIGS. 6A and 6B moreclearly illustrate the bifurcated locking clamp 22, which comprises alower cylindrical portion 32 and an upper circular flange 34. A pair ofgenerally axial suture channels 36 extend the full length of the device,as seen in FIG. 6B. Each of the suture channels 36 opens at a firstaperture 38 on a top face 40 of the circular flange 34, and graduallywidens to a lower aperture 42 at the bottom of the cylindrical portion32. The suture channels 36 are centered on a diametric plane through thelocking clamp 22, and their centers are spaced apart symmetricallyacross a central axis of the clamp.

As mentioned, the locking clamp 22 is bifurcated and forms two connectedhalves 44 a, 44 b across a variable sized slot 46 diametrically passingthrough the clamp in a vertical plane. The two halves 44 a, 44 b arejoined at the lower end of the device at a hinge 48; the hinge actuallycomprising separated hinge areas 48 of the lower cylindrical portion 32that connect both sides of the two suture channels 36. The hinge areas48 therefore define a living hinge. As such, the suture channels 36 arenot fully formed cylinders, but are defined by two partial conicalsurfaces on the inner wall of each of the halves 44 a, 44 b juxtaposedacross the slot 46. Alternatively, a true hinge may be provided betweenthe two halves 356.

As seen in FIGS. 6A and 6B, the inner wall of each half 44 a, 44 b ofthe clamp 22 features a partial cylindrical cutout 50 extending downwarda short distance from the top face 40 of the circular flange 34; thecutouts 50 being mirror images of each other across the slot 46 so as todefine a dead-end retention pin channel 52 for receiving the retentionpin 24. The retention pin channel 52 terminates at a bottom ledge 54, asseen in FIG. 6B, which limits advancement of the retention pin 24downward into the clamp slot 46. The retention pin 24 includes anenlarged head 58 and a shaft 60. The shaft 60 desirably has the sameradius as the radius of the cutouts 50.

In the absence of the retention pin 24 and sutures 30 a, 30 b, such asseen in FIG. 6A, the two clamp halves 44 a, 44 b extend in parallelacross the slot 46 a predetermined distance apart. In this relaxedconfiguration, each suture channel 36 defines a gradually increasingdiameter from the upper first aperture 38 to the lower second aperture42. Because of the connecting hinge areas 48, the second aperture 42maintains a constant diameter throughout usage of the device 20, and islarger than the diameter of the sutures 30 a, 30 b. However, because ofthe vertically extending slot 46, the upper ends of the two halves 44 a,44 b may be forced farther apart or closer together, pivoting relativeto each other about the lower hinge, and thus the diameter of the firstapertures 38 varies depending on the size of the slot 46.

Prior to use, the two halves 44 a, 44 b are forced apart so that theretention pin shaft 60 may be inserted into the retention pin channel52, as seen in FIGS. 4 and 5A. Preferably, the device 20 ispre-assembled by the manufacturer, i.e. the retention pin 24 and coilspring 26 are pre-assembled with the clamp halves 44 a, 44 b. Thesurgeon or technician would only need to feed the sutures 30 a, 30 bbetween the clamp halves 44 a, 44 b at which point the device is readyto deploy manually or using a delivery tool such as described below withrespect to FIGS. 9 and 10. The shaft 60 may bottom out in the pinchannel 52, against the bottom ledge 54, or may be only partiallyinserted into the pin channel. With the retention pin 24 insertedbetween the two halves 44 a, 44 b of the locking clamp 22, the suturechannels 36 are larger than the sutures 30 a, 30 b, permitting freepassage of the sutures longitudinally through the device 20. It may bebeneficial to create a nominal amount of friction between the upper endof the conical suture channels 36 and the sutures 30 a, 30 b to enablemore controlled adjustment of the device 20 along the sutures, in whichcase the diameter of the first apertures 38 may be slightly smaller thanthe diameter of the sutures 30 a, 30 b when the retention pin 24 ispresent. Furthermore, the spacing of the cutouts 50 across the slot 46is desirably slightly less than the diameter of the retention pin shaft60, such that the retention pin 24 slightly wedges apart the two halves44 a, 44 b.

The preceding discussion of inserting the retention pin 24 into thelocking clamp 22, and passage through the device 20 of the sutures 30 a,30 b desirably occurs while the coil spring 26 surrounds the clamp, andspecifically the lower cylindrical portion 32 of the clamp. The coilspring 26 has a relaxed inside diameter that is smaller than thediameter of the lower cylindrical portion 32 of locking clamp 22. Assuch, the coil spring 26 biases the two halves 44 a, 44 b toward eachother, causing their upper ends to pivot toward each other about thelower hinge in the absence of any restraint. The retention pin 24, wheninserted, provides such a restraint against inward movement of the twohalves 44 a, 44 b, and thus permits adjustment of the device 20 alongthe sutures 30 a, 30 b. When the retention pin 24 is removed, the coilspring 26 forces the two halves 44 a, 44 b radially together, thusreducing the size of the upper ends of the suture channels 36 to clampinward against the sutures 30 a, 30 b. Once again the lower ends of thesuture channels 36, and in particular the second apertures 42, remainunchanged. Because the inner walls of the two halves 44 a, 44 b aresubstantially parallel, and parallel to the coil spring 26 axis, theforce on the sutures is radial, thus eliminating any possibility ofslippage from axial forces.

At this stage it is important to understand that the coil spring 26provides a relatively uniform inward biasing force to the two halves 44a, 44 b, thus causing the halves to come together with the same force atthe top as at the bottom. This helps better retain the sutures 30 a, 30b since it maximizes the available surface area for gripping with auniform force. The coil spring 26 thus provides an inward biasing forcethat is axially uniform, and thus could be replaced with any similarbiasing member, such as a sleeve of elastic (e.g., silicone) material,or the like. Furthermore, though a coil spring 26 is advantageous forits relative economy and durability, the inward radial forces itsupplies around the entire periphery of the locking clamp 22 could bereplaced with a biasing member that simply applied compressive forces inthe direction perpendicular to the plane between the two halves 44 a, 44b. For instance, the locking clamp 22 itself could possess sufficientstiffness and be formed in such a way that removing the retention pin 24causes the two halves 44 a, 44 b to come together and retain the sutures30 a, 30 b without a surrounding spring. In such a configuration, a lockof sorts may also be provided to keep the two halves 44 a, 44 b togetheronce they have clamped the sutures, and prevent outward creep.Alternatively, a spring with a more uni-directional action may bedeployed around the locking clamp 22 to bias the two halves 44 a, 44 btogether, such as a C-shaped clip or leaf spring, or the like. In short,the device 20 includes the two halves 44 a, 44 b and some sort ofbiasing force that causes them to come together upon removal of theretention pin 24.

In use, the technician assembles the device 20 with the retention pin 24positioned in the retention pin channel 52 so as to force the two halves44 a, 44 b apart against the radial compressive force of the coil spring26. To facilitate this assembly, the lower end of the retention pinshaft 60 may be slightly tapered to facilitate introduction into theretention pin channel 52. The sutures 30 a, 30 b are threaded throughthe respective suture channels 36, preferably from the lower end throughthe larger second apertures 42 and upward through the device. Asmentioned, the sutures 30 a, 30 b may be free ends of a suture loop thatpasses through soft tissue and through a heart valve sewing ring.Subsequently, the user advances the suture locking device 20 down thesutures 30 a, 30 b to the desired location, such as against the heartvalve sewing ring. Adjustment of the sutures 30 a, 30 b through thedevice 20 results in a desirable tension in the sutures, at which pointthe user removes the retention pin 24 from the retention pin channel 52.The coil spring 26 instantaneously forces the two halves 44 a, 44 btogether, pinching or clamping down on the sutures 30 a, 30 b. As willbe described below, additional frictional features may be providedwithin the suture channels 36 to enhance the grip against the sutures.Finally, the remaining lengths of the sutures 30 a, 30 b extending abovethe device 20 are severed flush with the top face 40 of the circularflange 34. An exemplary tool for delivering and installing the suturelocking device 20 is described below in reference to FIGS. 10 and 11.

The suture locking clamp 22 shown in FIGS. 6A and 6B features a verticalslot 46 and a lower horizontal hinge 48. An alternative locking clamp22′ shown in FIG. 7 includes essentially the same elements as describedabove such that similar numerals with a prime (′) designation areutilized. The alternative locking clamp 22′ has two halves 44 a′, 44 b′separated across a vertical, diametric slot 46′. However, instead of alower horizontal hinge, the locking clamp 22′ has a vertical hinge 48′connecting the two halves 44 a′, 44 b′. The locking clamp 22′ desirablyfunctions similarly to the earlier described clamp when combined with aretention pin and exterior coil spring, though the two halves 44 a′, 44b′ pivot toward and away from one another about the vertical hinge 48′.Because of the different distances from the hinge 48′, the suturechannel 36′ farther from the hinge experiences greater size changes thanthe channel closer to the hinge. Consequently, the relaxed size of thesuture channel 36′ farther from the hinge may be slightly greater thanthe size of the channel closer to the hinge so that they both apply thesame amount of frictional clamping force on the sutures passingtherethrough upon removal of the retention pin.

An alternative suture locking device 70 shown in FIG. 8 includes just aninternal locking clamp 72 and an external coil spring 74 which cooperateto lock the position of the device along a pair of sutures 76 a, 76 b.In this embodiment, the coil spring 74 presses directly against theoutside of the sutures 76 a, 76 b and pinches or clamps them againstcutouts 78 formed in the outer surface of the locking clamp 72. Tomaintain the relative positions of the locking clamp 72 within the coilspring 74, the locking clamp may include outwardly projecting elementsthat engage the spaces between the coils of the spring. Furthermore, toadjust the device 70 along the sutures 76 a, 76 b, the free ends 80 ofthe coil spring 74 may be held in a position which forces open thespring so as to relax its inward compressive force against the sutures.At the appropriate position and tension within the sutures 76 a, 76 b,the restraining force on the free ends 80 is released such that the coilspring 74 tends toward its relaxed configuration, which produces aradially inward force against the sutures, forcing them into the cutouts78. As will be explained below, additional frictional features may beprovided in the cutouts 78.

A still further alternative suture locking device 90 shown in FIGS. 9Aand 9B includes a locking clamp having separate clamp halves 92 a, 92 bsurrounded by an exterior coil spring 94 and having a two-prongedretention clip 96 therebetween. External flanges 97 on both ends of theclamp halves 92 a, 92 b maintain alignment of the halves with the coilspring 94. That is, the outward flanges 97 on opposite axial ends retainthe coil spring 94 in position around the locking clamp. The inner wallsof the clamp halves 92 a, 92 b are separated across a slot 98 throughwhich pass two lengths of sutures 100. The coil spring 94 biases the twoclamp halves 92 a, 92 b toward each other to reduce the size of the slot98, but the presence of the retention clip 96 maintains an adequate slotwidth for adjustment of the device 90 along the sutures 100. Althoughnot shown, the clamp halves 92 a, 92 b may feature cutouts for receivingthe sutures 100 as in the embodiment of FIGS. 4-6.

Prior to use, a technician assembles the suture locking device 90 asseen in FIG. 9A by positioning the retention clip 96 between the clamphalves 92 a, 92 b and the sutures 100 through the slot 98. Desirably,the device 90 is pre-assembled by the manufacturer, i.e. the retentionclip 96 and coil spring 94 would already be assembled with the clamphalves 92 a, 92 b. The surgeon or technician would only need to feed thesutures 100 between the clamp halves 92 a, 92 b at which point thedevice is ready to deploy using a tool such as described below. Theretention clip 96 includes an upper bridge 102 joining two prongs 104.Each prong 104 includes a lower free end 106 and an upper angled portion108 connected to the bridge 102. The angled portions 108 relocate theposition of the bridge 102 out of direct alignment with the slot 98 suchthat the sutures 100 pass directly through the slot and may extendvertically upward. This offset also makes it easier to grab the bridge102 by a deployment tool, as will be seen. The length of the lower freeend 106 of each prong 104 is sufficient to maintain an even spacingbetween the inner walls of the clamp halves 92 a, 92 b against theinward bias of the coil spring 94.

In use, the suture locking device 90 in the configuration shown in FIG.9A is advanced along the sutures 100 to the desired position. Afterproper adjustment of the tension in the sutures, the user removes theretention clip 96, as seen in FIG. 9b . The coil spring 94 has an innercoil diameter that forces the two clamp halves 92 a, 92 b toward eachother so as to pinch or clamp the sutures 100 therebetween. Once again,additional frictional features may be provided on the inner walls of theclamp halves 92 a, 92 b, as will be described below with respect toFIGS. 12 and 13.

Now with reference to FIGS. 10 and 11, an exemplary delivery anddeployment tool 120 is shown and described. The illustrated deploymenttool 120 primarily includes a proximal handle 122, an elongated tube124, and an actuation rod 126. A trigger 128 causes longitudinalmovement of the actuation rod 126 when depressed, through variousmechanical means in the handle 122 that are well-known in the art andthus are not shown or described.

A distal end of the elongated tube 124 is shown enlarged in FIG. 11engaging a suture locking device, such as the device 90 of FIGS. 9A-9B.More specifically, the distal end of the tube 124 contacts the upperflanges 97 of the device 90 such that the majority of the deviceprojects distally from the tube while the retention clip 96 extends intothe tube. A hook 130 on the distal end of the actuation rod 126 engagesthe bridge of the retention clip 96. The advantageous angled shape ofthe retention clip 96 facilitates this assembly. The sutures 100extending through the device 90 pass outward through side apertures 132formed in the tube 124. Although not shown, the sutures 100 may continuein a proximal direction along the tube 124 to a location outside of thesurgical site. For example, if the tool 120 is used for installing thesuture locking device 90 on the proximal side of a heart valve sewingring, the sutures 100 represent two of a plurality of such sutures thatare preinstalled at the annular site and pass through the heart valvesewing ring to a location outside the patient's body.

The proximal movement arrow 134 indicated in FIG. 11 shows displacementof the actuation rod 126 upon depression of the trigger 128. This actionpulls the retention clip 96 from within the two halves 92 a, 92 b of thelocking device 90, and enables the coil spring 94 to compress the twohalves against the sutures 100 passing therethrough. Pulling the trigger128 thus deploys the device 90. At this point the deployment tool 120may be removed and the sutures 100 severed. Alternatively, edges of theside apertures 132 may be formed sharp so that rotation, axial movement,or other manipulation of the tool 120 causes the side apertures 132 tosever the sutures 100.

FIG. 12 is a sectional view perpendicular to the slot 98 through thesuture locking device 90 of FIGS. 9A-9B, while FIG. 13 illustrates aninside wall of one of the clamp halves 92. A series of angled ramps orteeth 140 are provided on the inner wall of the clamp half 92 to enhancefriction between the device 90 and sutures 100 passing therethrough. Inthe illustrated embodiment, each of the angled teeth 140 slopes inwardfrom a lower edge 142 to an upper edge 144. The lower edge 142 may lieflush with the borders 146 of the inner wall. When the two halves 92clamp inward against the sutures 100, the angled teeth 140 help preventrelative sliding movement of the sutures downward through the device or,stated another way, help prevent loosening of the device from itsclamped position. At the same time, the one-way gripping nature of theangled teeth 140 enable the surgeon to increase tension in the portionof the sutures 100 below the suture locking device 90 even after thedevice has been actuated. That is, the device 90 can be slid down thesutures 100 after actuation against the force of the coil spring 94without too much difficulty. It should be understood that the angledteeth 140 are exemplary only, and representative of numerousconfigurations of enhanced friction within the clamp halves 92. Forexample, the inner wall may be roughened or provided with bumps, orseries of horizontal ridges may be used.

FIGS. 14 and 15 illustrates an exemplary procedure for securing a heartvalve to a native annulus. Initially, the heart valve is shown in FIG.14 after having been advanced along an array of sutures 100 that werepreinstalled at the annulus. The sutures 100 pass upward through asewing ring 150 of the heart valve in the same positions as they areinstalled at the annulus. Typically, a single suture passes down and upthrough the annulus to form a loop, and the suture pairs 100 shownrepresent a single loop. A deployment tool, such as the tool 120 shownand described above, is then used to advance a suture locking device,such as the device 90 of FIGS. 9A-9B, along a suture pair 100 until itreaches the proximal side of the sewing ring 150, as seen in FIG. 15. Atthis point, the free ends of the suture pair extending out of theimplantation site may be pulled so as to appropriately adjust thetension in the sutures 100. Subsequently, actuation of the deploymenttool 120 “activates” the locking device 90, such as by pulling free theretention clip 96, thus clamping the device onto the sutures 100. Thissecures the sewing ring 150 between the device 90 and the annulus. Aplurality of the devices 90 are used around the heart valve as shown,typically between 8-16, and more preferably around 12. Alternatively,just three (3) of the locking devices 90 may be used for “hybrid”implants which feature an expandable anchoring structure, the threesuture loops acting more as guides to orientation of the valve thananchors. Such a hybrid approach is seen in U.S. Ser. No. 13/167,639 toPintor, et al., filed Jun. 23, 2011, the disclosure of which isexpressly incorporated herein.

One particular advantage of the suture locking devices disclosed hereinis their relatively small size, enabling installation of a plurality ofthe devices around a heart valve sewing ring without adding significantbulk. For example, both the height and outer diameter of the variousdevices disclosed herein are desirably about 2 mm or less, and may be assmall as 1 mm (i.e., between about 1-2 mm). The small size is enabled bythe relatively large radial forces generated by the exterior coilsprings as compared to the axial forces for the same spring. That is,for a given radial displacement of a single coil of a spring, the forcein the radial direction is thousands of times higher than the force inthe axial direction for the same axial displacement. Adding coils to thedevice adds to the radial force for a given radial displacement, but fora spring used axially, adding coils reduces the force. In other words, aspring with three coils produces three times the radial force comparedto a single coil, whereas a spring with three coils used in the axialdirection produces only ⅓ the axial force of a single coil in the axialdirection. Because of the relatively large amount of force a spring cangenerate in the radial direction, a relatively small spring can be usedto generate significant clamping forces, thus allowing for a very smalldevice.

In a preferred embodiment, the various embodiments of the suture lockingdevices are made of biocompatible material, including a coil springStainless Steel, Cobalt-Chromium, Nitinol, or the like. For the clamphalves, any bio-compatible polymer (e.g., Nylon, Delrin, polypropylene)would be suitable, though metallic materials could also be used. Theretention members (i.e., pin 26, clip 96) are desirably metallic toprovide good compressive strength against the force of the coil spring.One specific example of a spring has an axial length of between 1-2 mm,an inner coil diameter of about 15.7 μm (0.040″), a wire diameter ofabout 5.9 μm (0.015″), and three coils. An exemplary spring constant ison the order of 53.6 g/mm (3 lbf/in). Of course, these parameters areexamples only and a range of variations are possible. The miniaturenature of the devices, however, render them highly useful for heartvalve or annuloplasty ring implant suture anchors.

Further advantages of the devices disclosed herein are the speed andaccessibility of the deployment procedure. Since the device is verysmall it can be delivered on the end of a relatively long and thindelivery shaft where a surgeon's finger may not fit or reach. It isestimated that it takes approximately 15-30 seconds to install eachsuture locking device, including feeding the sutures through the device,attaching it to the delivery tool 120, and activating the device. Moreparticularly, the surgeon would first feed the sutures through one ofthe devices then through the end of the delivery tool. The retentionelement, such as the retention clip 96, is then engaged with the hook atthe end of the actuator rod in the delivery tool, and a single squeezeof the trigger pulls the device flush with the distal end of thedelivery tube. The surgeon then advances the device down the suture pairto the annulus, pulls the appropriate amount of tension on the sutures,then pulls the trigger again, which would retract the retainer out ofthe device, thereby activating it and allowing it to lock onto thesutures. The suture tails would also be cut at the end of the triggerstroke.

Moreover, in contrast with earlier suture locking devices, the presentdevice relies on strictly radial inward forces of the coil spring tocompress two clamp halves together, or to compress sutures against aclamp member. The clamp halves have parallel inner surfaces which arealso parallel to the coil spring axis, so that purely radial clampingforces are generated. Many earlier devices rely on a wedging actionbetween two surfaces, or between a wedge and surrounding surfaces, thussqueezing sutures between them. This utilizes an axial force of a springor other retention member, potentially leading to loosening of the lockif one of the clamping members slips axially. Furthermore, in theprocess of locking the device, the relative sliding of the two retentionsurfaces may modify the suture tension. In the devices of the presentapplication, the clamping members apply strictly radial forces,substantially instantaneously by removal of the retention pin or clip,which eliminates the risk of altering the suture tension. Furthermore,because the devices herein utilize springs to compress radially, muchmore clamping force is produced for a given size spring, which thereforeallows the devices to be advantageously miniaturized compared to thosewhich utilize an axial spring force. A locking device which uses anaxial spring necessarily requires a minimum spring height, which maydetrimentally interfere with certain implant procedures, such as heartvalve replacements.

With reference now to FIGS. 16A-16H, a number of steps in an exemplaryaortic heart valve implantation procedure illustrating the deployment ofthree suture locking devices, such as disclosed at 90 in FIGS. 9A and9B, on a proximal side of a heart valve sewing ring. The procedureutilizes a plurality of automated delivery devices 220 that are shown ingreater detail in FIGS. 17A and 17B.

FIGS. 16A-16H are sectional views through an isolated aortic annulus AAshowing a portion of the adjacent left ventricle LV and ascending aortaAO with outwardly bulging sinus cavities. The aortic annulus AA is shownschematically isolated and it should be understood that variousanatomical structures are not shown for clarity. The annulus AA includesa fibrous ring of tissue that projects inward from surrounding heartwalls. The annulus AA defines an orifice between the ascending aorta AOand the left ventricle LV. Although not shown, native leaflets projectinward at the annulus AA to form a one-way valve at the orifice. Theleaflets may be removed prior to the procedure, or left in place asmentioned above. If the leaflets are removed, some of the calcifiedannulus may also be removed, such as with a rongeur. The ascending aortaAO commences at the annulus AA with three outward bulges or sinuses, twoof which are centered at coronary ostia (openings) CO leading tocoronary arteries CA. As will be seen below, it is important to orientthe prosthetic valve so that its commissure posts are not aligned withand thus not blocking the coronary ostia CO.

The procedure illustrates the implant of a “hybrid” aortic prostheticheart valve 222 that includes a valve member 224 attached duringmanufacture to a lower coupling stent 226. The valve member 224represents a variety of different types of prosthetic heart valves, andas with many such valves includes a peripheral sewing ring 228 thatrests on the ascending aorta AO side of the inwardly-directed shelf-likeaortic annulus AA. The cloth-covered lower coupling stent 226 isdelivered in a collapsed configuration, and is ultimatelyballoon-expanded outward against the native leaflets or, if the leafletsare excised, against the debrided aortic annulus AA as shown. Furtherdetails of the illustrated hybrid valve 222 as well as a similar aorticimplant procedure are provided in U.S. Patent Publication No.2012/0065729, filed Jun. 23, 2011, the contents of which are expresslyincorporated herein.

Despite illustration of a particular procedure, it should be understoodthat the presently disclosed suture locking devices as well asinstruments for deploying and securing the locking devices are useful inother contexts than implantation of a prosthetic aortic heart valve. Forexample, the same suture locking devices can be used to replaceconventionally knotted sutures for prosthetic valve replacements atother native annuluses. Likewise, the suture locking devices can be usedto secure annuloplasty rings to any of the native annuluses. Morebroadly, the suture locking devices could be used in any surgicalenvironment in which sutures are used to secure objects or tissue inplace and typically require knotting. The suture locking devices replacethe function of the suture knots, and since they are more quicklydeployed they reduce the respective procedure times.

FIG. 16A shows a preliminary step in preparing an aortic annulus AA forreceiving the heart valve including installation of guide sutures 240.The surgeon attaches the guide sutures 240 at three evenly spacedlocations around the aortic annulus AA. In the illustrated embodiment,the guide sutures 240 attach to locations below or corresponding to thecoronary ostia CO (that is, two guide sutures are aligned with theostia, and the third centered below the non-coronary sinus). The guidesutures 240 are shown looped twice through the annulus AA from theoutflow or ascending aorta side to the inflow or ventricular side. Ofcourse, other suturing methods or pledgets may be used depending onsurgeon preference.

FIG. 16B shows the guide sutures 240 having been secured so that eachextends in pairs of free lengths from the annulus AA and out of theoperating site. The hybrid prosthetic heart valve 222 mounts on a distalsection of a delivery system 230 and the surgeon advances the valve intoposition within the aortic annulus AA along the guide sutures 240. Thatis, the surgeon threads the three pairs of guide sutures 240 throughevenly spaced locations around the sewing ring 228. If the guide sutures240, as illustrated, anchor to the annulus AA below the aortic sinuses,they thread through the ring 228 mid-way between the valve commissureposts. Thus, the guide sutures 240 pass through the sewing ring 228 atthe cusps of the valve and are less likely to become tangled with thevalve commissure posts. Furthermore, the exemplary sewing ring 228 hasan undulating inflow side such that the cusp locations are axiallythicker than the commissure locations, which provides more material forsecuring the guide sutures 240.

As seen in FIG. 16B, the valve delivery system 230 includes a heartvalve holder 232 which preferably includes three legs that extenddownward to the valve cusps. A tubular sleeve 234 connects to an upperhub of the valve holder 232, and a balloon dilatation catheter extendsthrough the assembly; a distal tip 236 of which is shown. As explainedbetter in U.S. Patent Publication No. 2012/0065729, mentioned above, thevalve delivery system 230 advances the prosthetic heart valve 222 downthe pairs of guide sutures and into place against the aortic annulus AA,at which time the balloon of the balloon dilatation catheter expands tooutwardly expand the cloth-covered anchoring skirt 226 against thesubvalvular wall.

FIG. 16C shows the hybrid heart valve 222 in phantom (for clarity) in adesired implant position. One of a plurality of automated deliverydevices 220 used to install suture locking devices of the presentapplication is shown schematically adjacent the delivery system 230. Asuture locking device 250 such as one of the devices describedpreviously is held at a distal end of a hollow tube 251 of the deliverydevice 220. One pair of the guide sutures 240 is shown being threadedthrough a capture loop 252 on the distal end of the delivery device 220by forceps 254. FIG. 16D shows the pair of guide sutures 240 beingthreaded through the suture locking device 250 and through the hollowtube 251 by pulling on a suture snare having an upper loop 256 connectedto the capture loop 252. Ultimately, the guide sutures 240 are pulledproximally through the entire delivery device 220 and held outside theimplantation site. FIG. 16E then shows advancement of the deliverydevices 220 toward the hybrid heart valve 222 until the suture lockingdevices 250 abut the sewing ring 228 thereon.

In FIG. 16F, forceps 254 are used to bend outward upper ends of thehollow tubes 251 of the delivery devices 220 to improve access to theheart valve 222 and implant site. The delivery tubes may be made of aneasily bendable or malleable material, such as aluminum, or could be aseries of linked elements that provide axial stiffness yet lateralflexibility. FIG. 16G shows expansion of the cloth-covered anchoringskirt 226 on the hybrid heart valve 220 against the subvalvular wall andsubsequent removal of the delivery system 230. The surgeon actuates thedelivery devices 220 to clamp the suture locking devices 250 onto theguide sutures 240, as will be explained below. Finally, FIG. 16H showsdetachment of the delivery devices 220 from the suture locking devices250 and removal of the tubes from the implantation site.

FIGS. 17A and 17B show an exemplary automated delivery device 220 usedin the procedure illustrated in FIGS. 16A-16H in both sectional andperspective views. As mentioned, the suture locking device 250 is heldon the distal end of the hollow tube 251, preferably by an interferencebetween a small nib 260 on an upper end of the locking device 250 and aninner lumen of the hollow tube 251. Aside from this engagement with thedelivery device 220, the locking device 250 may be identical to thesuture locking device 90 shown in FIGS. 9A and 9B, and includes alocking clamp having separate clamp halves 264 surrounded by an exteriorcoil spring 262 and having a two-pronged retention clip 266therebetween.

As described above, the suture snare has the upper loop 256 whichconnects to the capture loop 252 via one or more filaments 270 thatextend through the hollow tube 251 the entire length of the device 220.The capture loop 252 may be held open by a removable silicone ring 272that has an exterior channel so that it does not slip free of thecapture loop. It will be understood that the entire suture snareincluding the silicone ring 272 can be easily pulled upward through themiddle of the locking device 250 and delivery device 220. The captureloop 252, filaments 270 and upper loop 256 may be made of a flexible andstrong material, such as suture thread.

A locking device release button 280 is located at the upper end of thedelivery device 220 and attaches to a pair of filaments 282 that extenddownward either through or along the outside of the hollow tube 251. Theillustrated bottom, the filaments 282 extends along the outside of thetube 251 and pass inward through a pair of side apertures 284 at thelower end of the tube. The two filaments 282 are then secured to theretention clip 266 held in the locking device 250. Tension in thefilaments 282 can pull the retention clip 266 upward, thus actuating thelocking device 250. It is important to note that the filaments 282perform an equivalent function as the actuation rod 126 seen in FIGS. 10and 11, and the two configurations may be commonly termed elongatedtension members.

With reference back to the procedure step of FIGS. 16C-16E, the lockingdevice release button 280 is shown separated from an upper end of thehollow tube 251. This permits passage of the suture snare and guidesutures 240. As seen in FIG. 16F, the release button 280 may betemporarily secured on the upper end of the hollow tube 251 for part ofthe procedure to reduce clutter at the operating site. After removal ofthe valve delivery system 230, as in FIG. 16G, the surgeon pulls therelease button 280 which tensions the filaments 282 and pulls theretention clip 266 upward, thus actuating the suture locking device 250.The same procedure is carried out for as many of the delivery device220/locking device 250 combinations there are (in the illustratedembodiment, just three). Ultimately, the hybrid heart valve 220 issecured in place at the annulus by the locking devices 250 as well asthe outwardly expanded anchoring skirt 226. After each locking device250 is actuated, the associated delivery device 220 can simply beremoved. Desirably, removal of the retention clip 266 allows the twoclamp halves 264 (see FIG. 17B) to come together a little to relieve theinterference with the tube 251.

FIGS. 18 and 19 are longitudinal sectional views of alternativemechanisms for temporarily tensioning sutures to the automated deliverytubes disclosed herein. In FIG. 18, a tensioning assembly 290 includesan annular cap 292 affixed to the proximal end of the delivery device220 on which a lever arm 294 pivots. The lever arm 294 has teeth or asimilar expedient at a distal end that engages similar teeth 296 on aninner wall of the annular cap 292, the lever arm being biased by aspring 298 toward the teeth 296. A user can feed the guide suture 240between the engaging teeth 296 while pulling back the lever arm 294, andthen release the lever arm 294 to grab the suture with the teeth. Thispermits easy adjustment of the tension in the guide suture 240 and thenfees up the surgeon to concentrate on the other aspects of valve implantbefore the locking device 250 is actuated.

Likewise, FIG. 19 shows a tensioning assembly 300 on the proximal end ofthe delivery device 220 comprising a rotatable cleat 302. The surgeonwraps the guide suture 240 around the cleat 302 until frictional forceshold it in place, and then can tighten or loosen the tension by rotatingthe cleat 302. Of course, other such arrangements are contemplated.

The present application also contemplates a “side-entry” suture lockingclamp 350, as shown in FIGS. 20-25. As before, the clamp 350 provides asuture locking retainer which eliminates the need for tying knots insurgical sutures. The suture locking clamp 350 includes a bifurcatedclamp member 352 having an axial hinge 354, like in FIG. 7. The clampmember 352 can be manufactured from plastic by molding. The clamp member352 has two substantially identical halves 356 a, 356 b separated by avariable-sized slot 358 and biased together by at least one exterior “C”clip 360. The axial hinge 354 is desirably a “living hinge” formed inthe molded part along one side so that the halves 356 a, 356 b can pivotapart to vary the size of the slot 358 and form an opening on the sideopposite from the hinge in which sutures can be inserted. Alternatively,a true hinge may be provided between the two halves 356.

One or more of the C-clips 360 are placed around the clamp and sizedsuch that they apply a force which acts to close the clamp 352 and closeor eliminate the slot 358, thus clamping onto sutures that pass throughthe slot. The C-clip(s) 360 thus provide the biasing member positionedon the outside of the clamp member 352 having a relaxed size that, inthe absence of any other object in the slot 358, urges the innersurfaces of the clamp halves 356 together such that the slot has a widthsmaller than the suture thickness. In an alternative configuration, asection of tube with a slit (forming a “C” in cross section) couldreplace the array of “C” clips. Indeed, the term, “biasing member”should be understood to refer to one or more elements as describedherein.

As with the earlier embodiments, an overall exemplary size of the devicecan be 2 mm in height and diameter, or smaller. The initial design shownhere is based on 2-0 sutures, which are commonly used in valvereplacement procedures. Furthermore, the dimensions and parameters formaterials described above for the earlier embodiments also apply to thelocking clamp 350 of FIGS. 20-25.

As seen in FIG. 21, each half 356 includes a semi-cylindrical middlerecess 362 between two outwardly-projecting end flanges 364. When thetwo halves 356 are brought together, they define a spool shape. As seenin FIGS. 20A, 20B, the C-clips 360 are received in the recess 362 withtheir open ends 366 flanking the variable-sized slot 358 and directlyopposed to the hinge 354. The end flanges 364 hold the C-clips 360 inplace.

The C-Clips 360 would most likely be formed from Nitinol wire, althoughother materials such as stainless steel should not be excluded. For theexemplary embodiment shown, the C-clips 360 are formed from 0.008″diameter wire and have an outside diameter of 0.079″ (2 mm) Theillustrated embodiment incorporates five C-clips 360, though additionalC-clips 360 could be added to increase the clamping force. Additionally,the clamping force can be increased significantly by small increases inthe wire diameter of the C-clips 360. The bending stiffness of acircular wire is proportional to the 4^(th) power of its diameter, andso increasing the wire diameter from only 0.008″ to 0.010″ increases theclamping force by a factor of 2.4, while an increase to 0.012″ wouldresult in a 5-fold increase in clamping force. Thus by changing thenumber of C-clips and their wire diameters, large changes in theclamping force can be realized with minimal impact on the devicediameter and small changes in clamp height.

FIGS. 24A-24D illustrate a sequence of operation of the side entrysuture locking clamp 350. First, the assembled locking clamp 350includes the aforementioned components as well as a retention pin 370.Prior to use, the two halves 356 a, 356 b are forced apart so that theretention pin 370 may be inserted into a retention pin channel 372, asseen best in FIG. 22. The retention pin channel 372 is defined betweenthe axial hinge 354 and an axially-oriented retainer rib 374 formed onone or both halves 356 and extending into the slot 358. Release of thetwo halves 356 permits the C-clips 360 to force the two halves to pivottoward one another and clamp onto the retention pin 370. Preferably, theclamp 350 is pre-assembled by the manufacturer, i.e. the retention pin370 and C-clips 360 are pre-assembled with the clamp halves 356 a, 356b. The presence of the retention pin 370 holds open the two halves 356a, 356 b so that the slot 358 widens into the opening opposite the hinge354 into which one or more sutures 380 can be inserted.

As a first step in the process of deployment, the surgeon laterallydisplaces one of the suture locking clamps 350 toward one or moresutures 380, as seen in FIG. 24A. As mentioned, the slot 358 defines anopening into which the sutures 380 are received. As seen in FIG. 24B,the surgeon then tensions the sutures 380 while the suture locking clamp350 is held stationary or pressed (seated) against a stationarysubstrate, such as the proximal face of a prosthetic heart valve sewingring or annuloplasty ring. In FIG. 24C, the retention pin 370 isremoved, thus allowing the C-clips 360 to force closed the oppositehalves 356 a, 356 b of the clamp 352, thus clamping the suture(s) 380therebetween, as seen in FIG. 24D. Because the inner walls of the twohalves 356 a, 356 b are substantially parallel, and parallel to the axisof the C-clips 360, the force on the sutures 380 is radial, thuseliminating any possibility of slippage from axial forces.

In contrast with earlier suture locking clamps, the present clamp relieson strictly radial inward forces to compress the two clamp halvestogether. Many earlier clamps rely on a wedging action between twosurfaces, or between a wedge and surrounding surfaces, thus squeezingsutures between them. This type of fastener relies on an axial force ofa spring or other retention member, potentially leading to loosening ofthe lock if one of the clamping members slips axially. Furthermore, inthe process of locking the clamp, the relative sliding of the tworetention surfaces may modify the suture tension. In the clamps of thepresent application, the clamping members apply strictly radial forces,applied instantaneously by removal of the retention pin or clip, whicheliminates the risk of altering the suture tension. Furthermore, becausethe clamps described herein utilize C-clips or other such biasing memberto compress radially, much more clamping force is produced for a givensize spring as opposed to utilizing the axial force component of a coilspring. This allows the clamps to be advantageously miniaturizedcompared to those which utilize an axial spring force. A locking clampwhich uses an axial spring necessarily requires a minimum spring height,which may detrimentally interfere with certain implant procedures, suchas heart valve replacements.

With reference back to FIG. 22, the inner faces of one or preferablyboth of the clamp halves 356 a, 356 b include a plurality of gripmembers 382 that help prevent relative movement between the deployedclamp 350 and the sutures 380. More particularly, the grip members 382prevent relative longitudinal movement between the clamp 350 and sutures380 in only one direction. For example, the grip members 382 are formedas wedges with a ramp angled in one axial direction, in the illustratedembodiment the wedges are angled upward. Due to their orientation, andafter the clamp 350 has been deployed about sutures 380, the sutureswould be prevented from moving relatively downward, but could be pulledthrough upward. That is, even after actuation, the clamp 350 can be sliddown the sutures 380 against the force of the C-clips 360 without toomuch difficulty, but not upward. At the same time, the one-way grippingnature of the angled teeth 382 enables the surgeon to increase tensionin the portion of the sutures 380 below the suture locking clamp 350after it has been actuated. It should be understood that the angledteeth 382 are exemplary only, and representative of numerousconfigurations of enhanced friction within the clamp halves 356. Forexample, the inner wall may be roughened or provided with bumps, orseries of horizontal ridges may be used.

Desirably, both inner faces of the clamp halves 356 a, 356 b include anaxial bar 384 that helps retain the sutures 380 within the slot 358. Asseen in FIG. 24D, the bars 34 extends sufficiently inward toward eachother so as to close and present a barrier to lateral escape of thesutures 380.

It is important to understand that the C-clips 360 provide a relativelyuniform inward biasing force to the two halves 356 a, 356 b, thuscausing the halves to come together with the same force at the top as atthe bottom. This helps better retain the sutures 380 since it maximizesthe available surface area for gripping with a uniform force. As theC-clips 360 provide an inward biasing force that is axially uniform,they could be replaced with any similar biasing member, such as a sleeveof elastic (e.g., silicone) material, or the like. Furthermore, thoughthe C-clips 360 are advantageous for their relative economy anddurability, the inward radial forces they supply around the entireperiphery of the locking clamp 350 could be replaced with a biasingmember that simply applies compressive forces in the directionperpendicular to the plane between the two halves 356 a, 356 b. Forinstance, the locking clamp 350 itself could possess sufficientstiffness to cause the two halves 356 a, 356 b to come together andretain the sutures 80 without a surrounding spring. In such aconfiguration, a lock or latch may also be provided to keep the twohalves 356 a, 356 b together once they have clamped the sutures, andprevent outward creep. In short, the clamp 350 includes the two halves356 a, 356 b and some sort of biasing force that causes them to cometogether upon removal of a retention member, as will be clear below.

One particular advantage of the suture locking clamps 350 disclosedherein is their relatively small size, enabling installation of aplurality of the clamps around a heart valve sewing ring without addingsignificant bulk. For example, both the height and outer diameter of theclamps disclosed herein are desirably about 2 mm or less, and may be assmall as 1 mm (i.e., between about 1-2 mm). The initial design shownhere is based on 2-0 sutures, which are commonly used in valvereplacement procedures. Also, because of the relatively large amount offorce a C-clip 360 can generate in the radial direction, a relativelysmall clip can be used to generate significant clamping forces, thusallowing for a very small clamp.

In a preferred embodiment, the suture locking clamps 350 are made ofbiocompatible material, including Stainless Steel, Cobalt-Chromium,Nitinol, or the like for the C-clips 360. For the clamp halves, anybio-compatible polymer (e.g., Nylon, Delrin, polypropylene) would besuitable, though metallic materials could also be used. The retentionpin 370 is desirably metallic to provide good compressive strengthagainst the force of the C-clips 360. The miniature nature of the clampsrender them highly useful for heart valve or annuloplasty ring implantsuture anchors.

Another advantage of the suture locking clamps disclosed herein is therelow cost of manufacture. For example, the exemplary side entry lockingclamps 350 each comprises a molded component and several formed wireC-clips. Even if ten or more of the clamps are required for a procedure,the cost is much less than existing systems.

Further advantages of the clamps disclosed herein are the speed andaccessibility of the deployment procedure. Since the clamp is very smallit can be delivered from the end of a relatively long and thin deliveryshaft where a surgeon's finger may not fit or reach. It is estimatedthat it takes approximately 15-30 seconds to install each suture lockingclamp, including manipulating a delivery tool to capture sutures andactivating the clamp. More particularly, the surgeon would first passthe sutures through the side opening of one of the clamps and thenadvances the clamp down the suture pair to the annulus, pulls theappropriate amount of tension on the sutures, then retracts theretention pin 370 out of the clamp, thereby activating it and allowingit to lock onto the sutures. The suture tails would also be cut at theend of the trigger stroke.

FIG. 25 illustrates how the suture(s) 380 can be tensioned further afterdeployment of the clamp 350. It will be noted that only one suture 380is shown in this view to emphasize that one or more can be secured bythe clamp 350. The individual grip members 382 could be axially offseton the two halves 356 to enhance their frictional hold on the suture(s)380. In other words, deploying the clamp 350 creates a serpentine pathfor the suture(s) 380 between the alternating grip members 382. Thecross-section of the slot 358 shows the offset suture grips 382, whichthus act as a “one way” ratchet that allows for further tensioning ofthe suture(s) after deployment of the clamp, but resist loosening of thesutures.

FIG. 25 also shows an alternative clip/suture arrangement where one end390 of the suture 380 is fixed to the clamp member 352, such as byembedding a bead 392 or other such enlargement. That is, one end 390 ofthe suture pre-attaches to the one of the device halves 356 a, 356 b,which could be done by insert molding the end as shown, or simply tyingone end of the suture to the device. This means that the clamp 350 onlyclamps onto one suture 380, which might be easier to align in the clipand easier to consistently capture. This arrangement would be preferredfor robotic surgery where both ends of the suture are typically not runout of the incision. In a typical cardiac repair or replacementprocedure, the free end 380 of the suture having a suture needleattached thereto is passed down through the implant and the annulus,then back up through the implant in about the same location and pulledtaut so as to pull the locking clamp 350 against the implant. The freeend 380 is inserted through the clamp slot 358 and tensioned, whereuponthe retention pin 370 is removed to lock the clamp 350 onto the suture.In addition to the side entry clamp 350, this arrangement could also beutilized with the earlier embodiments where the sutures pass throughfrom end-to-end.

FIGS. 26A-26C illustrate an exemplary delivery system 400 for the sideentry suture locking clamps 350 described herein. In the illustratedembodiment, the system 400 is shown as a pistol-like device with a long,malleable shaft 402 extending from a proximal handle 404 having a grip406 and an actuation trigger 408. Of course, the system can be modifiedso that the handle 404 is generally aligned along the axis of the shaft402, with a slider as an actuator, or any other such configuration.

As seen in the detailed view of the distal end of the tubular shaft 402in FIG. 26C, a pair of sutures 410 is tensioned at a shallow angle withrespect to the shaft so as to enter a longitudinal channel 412 on oneside of the shaft and into the slot formed in one of the side entrysuture locking clamps 350. A pair of guides 414 project outward from theshaft 402 at the proximal termination of the channel 412 to helpmaintain alignment of the sutures 410 into the channel. An inner lumenof the shaft 402 has a diameter sufficient to receive a plurality ofpre-loaded suture locking clamps 350 in their undeployed configuration.A series of the locking clamps 350 are stacked axially against eachother within the tubular shaft 402 with their slots oriented toward theshaft channel 412.

FIG. 27 is an exploded perspective view of components of the side entrysuture locking device delivery system 400. FIG. 27A is an enlargedperspective view of a proximal end of one of the side entry suturelocking clamps 350, while FIG. 27B shows a stacked series 416 of theclamps from a distal end as would be loaded into the delivery system400.

The clamp delivery system 400 includes the aforementioned exterior shaft402, a series of the stacked locking clamps 350, an elongated retentionpin or cable 420, and an inner pusher tube 422 that slides within thelumen of the shaft 402. As seen in the sectional views of FIGS. 28A and28B, the retention cable 420 extends through a lumen within the pushertube 422 to the distal end of the shaft 402 and is positioned within thedistal most suture locking clamp 350. The retention cable 420 performsthe same function as the aforementioned retention pin 370 describedabove with reference to a single locking clamp 350. That is, the commonretention cable 420 extends through the series of locking clamps 350,maintaining each of them in its undeployed configuration. At the sametime, the retention cable 420 holds the series of locking clamps 350within the system 400. To enhance release of each suture locking clamp350, a small raised area 424 (see FIG. 29D) may be provided on one endof each half of the device to separate the devices from each other, asseen in FIG. 28B. These raised areas 424 of the proximal most clamp 350are received within a stepped bore 426 in the distal end of the pushertube 422.

In one embodiment, the retention cable 420 and pusher tube 422 aredisplaced axially by a movement mechanism (not shown) within theproximal handle 404. As will be described in more detail below, themovement mechanism is configured to retract the cable 420 proximallyrelative to the tube 422, and advance the cable 420 and tube 422together distally within the shaft 402. For example, depression of thetrigger 408 retracts the retention cable 420 within the pusher tube 422,and release of the trigger urges both the retention cable 420 and pushertube 422 distally within the shaft 402. In each trigger pull andrelease, the retention cable 420 retracts within the pusher tube 422 adistance equivalent to the axial height of one of the suture lockingclamps 350, and the cable 420 and tube 422 advance the same distance.

With reference to FIG. 28B, one of the suture locking clamps 350 isshown released from the series within the shaft 402. In one embodiment,the distal most locking clamp 350 while still being retained on theretention cable 420 is located beyond the end of the shaft 402, althoughthe locking device could also be partly or wholly within the shaft. Inthis position, the retention cable 420 extends substantially all the waythrough the distal most locking clamp 350, such as shown with the nextlocking device in FIG. 28B. Depression of the trigger 408 thenpulls/retracts the retention cable 420 a distance equal to the height ofthe locking clamp 350, thus deploying the distal most locking device, orin other words permitting the C-clips 360 to close the slot 358 aroundthe sutures 410. Placing the sutures 410 through the channel 412 andinto the slot 350 of the distal most locking clamp 350 ensures that thelocking device will engage the sutures when it is expelled. At thispoint, the surgeon releases the trigger 408 which causes axialadvancement of both the tension cable 420 and pusher tube 422, thusmoving the stack of locking clamps 350 and positioning the distal mostclamp either outside of the shaft 402 or in a location where it can beeasily released therefrom.

In a preferred embodiment, the sequence includes first proximaldisplacement of the retention cable 420 relative to the stack of suturelocking clamps 350 and to the pusher tube 422 to activate the distalmostclamp (i.e., cause it to clamp onto the sutures 410). Subsequently,distal displacement of both the pusher tube 422 and the retention cable420 ejects the distalmost clamp 350. This prevents ejection of a clamp350 prior to it being deployed onto the sutures 410, thus helping toavoid fugitive clamps.

In an alternative configuration, the retention cable 426 fixedlyattaches to the proximal handle 404 and thus remains with its distal endapproximately even with the distal end of the shaft 402, or slightlyrecessed therein. Only the pusher tube 422 attaches to a movementmechanism (not shown) within the proximal handle 404. Actuation of thetrigger 408 causes distal movement of the pusher tube 422 within theshaft 402. For example, actuation of the trigger 408 translates intodistal movement of the pusher tube 422 equivalent to the axial height ofone of the suture locking clamps 350. That is, pulling the trigger 408causes the pusher tube 422 to push one of the pre-loaded locking clamps350 out of the end of the shaft 402. Of course, once the suture lockingclamp 350 is expelled from the end of the shaft 402, it also releasesfrom the retention cable 420, thus causing its deployment. Thisconfiguration is slightly less desirable than the one described abovebecause during deployment the suture locking clamps 350 move relative tothe sutures 410 which are stationary. Nevertheless, the point is madethat there are a number of ways to expel one suture locking clamp 350 ata time from the distal end of the shaft 402 while the same timeretracting the retention cable 420 and engaging the sutures 110 with thelocking clamp.

It is important to understand that components of the various deploymenttools for the suture locking devices described herein could be modifiedand exchanged. That is, the retention cable 420 for the delivery system400 could be replaced by the actuation rod 126 of the deployment tool120 (FIG. 11) or the filaments 282 of the delivery device 220 (FIG.17B), and vice versa. In particular, each of the several suture lockingclamps (20, 70, 90, 350) disclosed herein includes a bifurcated clampmember defining a variable-sized slot which is biased toward a closedposition. A retention member, such as the retention cable 420, maintainsthe slot open so that one or more sutures can be inserted into the slot,and when the retention member is removed the slot closes onto thesuture(s). It should be understood that removing the retention membercan be accomplished in various ways, and a preferred embodiment is anelongated tension member extending along the deployment tool andactuated from a proximal end. In the delivery system 400 the retentioncable 420 defines the elongated tension member and the retention memberwithin the clamp member 352, while in the earlier-describedsingle-device embodiments the tension members and retention members areseparate elements. However, those of skill in the art will understandthat the delivery system 400 could be modified to be a single-devicetool and have separate tension members and retention members.

Preferably, the outer shaft 402 is malleable or bendable into variousshapes which significantly enhances the ability of a surgeon tocorrectly position the distal end of the system 400 as it advancestoward the target location. For example, access passageways into theheart during a surgical procedure are often somewhat confined, and maynot provide a linear approach to the annulus. Accordingly, the surgeonbends the shaft 402 to suit the particular surgery. Various materialsand constructions may be utilized for the malleable shaft 402. Forexample, a plurality of Loc-Line connectors could be used which provideaxial rigidity with bending flexibility. Another example is a plastictube having a metal coil embedded therein to prevent kinking In apreferred embodiment, an aluminum tube having a chromate (e.g., Iridite)coating is used. Aluminum is particularly well-suited for forming smalltubes that can be bent without kinking, but should be coated withIridite or the like to prevent deterioration in and reaction with thebody.

Furthermore, both the retention cable 420 and the pusher tube 422 aremade of flexible materials to complement the malleability of the shaft402. For example, the retention cable 420 could be a braided wire ropeor solid flexible wire. The pusher tube 422 could be made of a flexiblepolymer, though other materials are contemplated.

In a preferred embodiment, as seen in FIG. 29, the stacked series 416 ofthe side entry suture locking clamps 350 are bonded together. Forinstance, the raised areas 424 on the proximal end of each clamp 350 maybe bonded to the flat distal surface of the adjacent clamp to form acohesive chain. The clamps 350 may be bonded together such as by moldingthe locking clamp members 352 for each clamp as one long chain, with aweakened point at the junction between the raised area 424 of one clampand the next. The C-clips 360 for each can be added after the mold step.Alternatively, the clamps 350 may be connected with adhesive at the samepoint which has a relatively small surface area for easy detachment, orthe clamps can be snap-fit together in an interference fit. In eachcase, the chain of clamps 350 may be separated with a minimal amount offorce. This configuration contemplates connecting two or more clampstogether, and preferably the entire stack 416 of the clamps.

For instance, FIG. 30 shows one of the clamps 350 after expulsion fromthe distal end of the delivery system 400 showing one method ofseparating it from the adjacent clamp. That is, a slight twist of theouter shaft 402 should be sufficient to break the weak point between thedeployed clamp 350 and the next one. The physician may need to grab andhold the deployed clamp 350 with forceps, for example. The presence ofthe retention cable 420 clamped within all of the other clamps 350 stillwithin the shaft 402 should be sufficient to avoid separating more thanone at a time. That is, the clamps 350 in the stack 416 allcompressively engage the retention cable 420 and rotate together.

The advantage of bonding or otherwise linking the clamps 350 together isthat it greatly reduces the chance of losing one of the clamps 350during a surgery. That is, prior to deploying the clamps 350 by clampingthem to one or more sutures, they would be connected to each otherrather than loose. The surgeon can then verify that each suture lockingclamp 350 has securely engaged the sutures 410 prior to detaching itfrom the rest of the stack 416.

FIGS. 31A-31D show several steps in use of the delivery system 400 todeploy one of the side entry suture locking clamps 350 during aprosthetic heart valve implantation procedure. As was described withrespect to FIGS. 14 and 15 above, the heart valve 430 is shown in FIG.31A after having been advanced along an array of sutures 410 that werepreinstalled at the annulus. The sutures 410 pass upward through asewing ring 432 of the heart valve in the same positions as they areinstalled at the annulus. Typically, a single suture 410 passes down andup through the annulus to form a loop, and the suture pairs shownrepresent a single loop. The distal end of the delivery system 400 isshown advancing toward the annulus and heart valve 430 seated thereon.

FIG. 31B is an enlarged view showing the distal end of the system 400just prior to contact with the heart valve sewing ring 432. The pair ofsutures 410 that will be secured are routed into the channel 412 on oneside of the shaft 402. The shaft 402 is the advanced until its end orthe distal most locking clamp 350 contacts the sewing ring, as in FIG.31C. The suture guides 414 projecting outward from the shaft 402 helpmaintain the position of the sutures 410 as the surgeon pulls tension onthe sutures before activating the lock, as indicated in FIG. 31C.

At this point, the surgeon activates the movement mechanism within theproximal handle 404 by pulling the trigger 408 which deploys thedistal-most locking clamp 350 to clench the sutures 410, as was depictedin the detail of FIG. 28B. Momentarily, the trigger 408 remains in thefully depressed position, and the system 400 may be pulled free of thepair of sutures 400. The sutures 410 are then severed close to the clamp350. For this purpose, a knife edge (not shown) could be incorporatedinto the end of the shaft 402 to facilitate cutting the suture tailsafter each locking clamp 350 is deployed.

The next locking clamp 350 is then positioned for deployment byreleasing the trigger 408 which, as described above, simultaneouslyadvances the tension cable 420 and pusher tube 422 by a length equal toone locking device. The surgeon can then reposition the distal end ofthe shaft 402 around the heart valve sewing ring 432 toward the nextpair of sutures 410 to be secured. Because of the series of pre-loadedclamps 350 all of the pairs of sutures 410 can be secured and the valve430 anchored to the annulus in a very short time. This greatlysimplifies the use of the system and saves valuable OR time as well ason-pump time when used in open heart procedures. A less complicated andmore inexpensive version could be made with a single locking clamp 350per delivery system, which could be more practical when only 3 or soclamps needed to be used for a particular procedure, as opposed to 12-20for a conventional surgical valve replacement.

The suture locking clamps and deployment systems disclosed herein areparticularly suitable for eliminating knot-tying in surgical valvereplacement, such as for implanting a prosthetic aortic valve, surgicalvalve repair (i.e., annuloplasty), or in general wherever sutures areused in surgery. They could be used with standard surgical valves wherethere are 10 or more pairs of sutures (e.g., 12-20), or with the EDWARDSINTUITY valve system from Edwards Lifesciences of Irvine, Calif. toeliminate the need for knot tying of three pairs of sutures locatedequidistantly around the sewing ring. Another possibility would be toincorporate suture locking clamps within a pre-positioned tube andreplace the proposed snares/tubes used for anchoring the EDWARDS INTUITYvalve system during deployment Likewise, the clamps could bepre-attached to the sewing ring of an aortic or mitral valve. Forinstance, the sewing ring could incorporate radial slits adjacent toembedded suture locking clamps such that after the sutures were placedin the annulus they would simply be guided through the slits and intothe slots of the devices. Each suture pair could then be tensioned andthe lock engaged.

Another advantage of the suture locking clamps disclosed herein is theirlow cost of manufacture. For example, the side entry locking clamps 350comprise a molded component and several formed wire C-Clips. Even if 10or more of the devices are required for a procedure, the cost is muchless than existing systems.

Despite illustration of a particular procedure, it should be understoodthat the presently disclosed suture locking clamps as well asinstruments for deploying and securing the locking clamps are useful inother contexts than implantation of a prosthetic aortic heart valve. Forexample, the same suture locking clamps can be used to replaceconventionally knotted sutures for prosthetic valve replacements atother native annuluses (e.g., mitral, tricuspid). Likewise, the suturelocking clamps can be used to secure annuloplasty rings to any of thenative annuluses. More broadly, the suture locking clamps could be usedin any surgical environment in which sutures are used to secure objectsor tissue in place and typically require knotting. The suture lockingclamps replace the function of the suture knots, and since they are morequickly deployed they reduce the respective procedure times.

While embodiments and applications of this invention have been shown anddescribed, it would be apparent to those skilled in the art that manymore modifications are possible without departing from the inventiveconcepts herein, and it is to be understood that the words which havebeen used are words of description and not of limitation. Therefore,changes may be made within the appended claims without departing fromthe true scope of the invention.

What is claimed is:
 1. A knotless method for anchoring a cardiac implantto a native valve annulus, the implant having been advanced to thenative valve annulus down a plurality of lengths of suture that arepreinstalled at the native valve annulus and threaded through and arounda periphery of the implant, the sutures having a thickness, the methodcomprising: providing an elongated delivery tool having a delivery tubewith a proximal end, a distal end, and a lumen therein, and an elongatedretention member that extends through the lumen of the delivery tube;loading a plurality of axially stacked suture locking clamps into thelumen of the elongated delivery tool, wherein the elongated retentionmember extends through each of the suture locking clamps; engaging aselect one of the preinstalled lengths of suture with a distal mostsuture locking clamp positioned at the distal end of the delivery tube;advancing the distal end of the elongated delivery tool to the cardiacimplant; retracting the retention member relative to the stack of suturelocking clamps from within just the distal most suture locking clamp soas to enable the distal most suture locking clamp to clamp onto theselect one of the preinstalled lengths of suture; severing the selectone of the preinstalled lengths of suture clamped by the distal mostsuture locking clamp; and sequentially repeating the steps of engaging,advancing, retracting and severing for a plurality of the suture lockingclamps around the periphery of the implant.
 2. The method of claim 1,wherein each suture locking clamp includes a pair of clamp halves eachhaving an inner surface facing the inner surface of the other clamp halfand a biasing member urging the inner surfaces of the clamp halvestoward each other, wherein the elongated retention member extendsthrough and is imposed between the inner surfaces of the clamp halves ofeach suture locking clamp to maintain a slot in each wide enough for thelengths of suture to pass through, and wherein the step of retractingthe retention member enables the biasing member to urge the innersurfaces of the clamp halves together and clamp onto the select one ofthe preinstalled lengths of suture.
 3. The method of claim 2, whereinthe clamp halves are hinged together on a first circumferential sidesuch that the slot opens on the side opposite the first circumferentialside, and wherein the biasing member comprises a plurality of C-clipsarranged around the clamp member with free ends of each C-clip locatedon either side of the slot opposite the first circumferential side. 4.The method of claim 2, wherein the elongated delivery tool has alongitudinal channel commencing at the distal end and extendingproximally along the delivery tube, and the step of engaging includesintroducing the select one of the preinstalled lengths of suture into atleast the slot of the distal most suture locking clamp by passing theselect one of the preinstalled lengths of suture radially inward throughthe longitudinal channel of the delivery tube.
 5. The method of claim 2,wherein each suture locking clamp has a plurality of grip members on theinner surfaces of the clamp halves that are oriented to prevent relativelongitudinal movement between the suture locking clamp and the lengthsof suture in only one direction such that the suture locking clamp maybe urged distally along the lengths of suture but not proximally, themethod including adjusting tension in the select one of the preinstalledlengths of suture clamped by the distal most suture locking clamp byurging the distal most suture locking clamp distally along the selectone of the preinstalled lengths of suture prior to the step of severing.6. The method of claim 1, wherein the delivery tool further includes apusher tube located within the delivery tube and in contact with aproximal most suture locking clamp in the stack of suture lockingclamps, and the method further includes, after the step of retracting,distally displacing the pusher tube to advance the distal most suturelocking clamp out of the delivery tube.
 7. The method of claim 6,wherein the delivery tool further includes a trigger on a proximalhandle configured to, with one pull and release, first retract theretention member relative to the stack of suture locking clamps and tothe pusher tube, and then distally displace both the pusher tube and theretention member to advance the distal most suture locking clamp, themethod including actuating the trigger to deploy the distal most suturelocking clamp onto the suture.
 8. The method of claim 1, wherein thedelivery tube is formed of a manually malleable material to enablebending by a surgeon, and the retention member is flexible to avoidimpeding bending of the delivery tube, the method including bending thedelivery tube in conjunction with the step of advancing.
 9. The methodof claim 1, wherein the suture locking clamps are bonded together in thestack with a weak point therebetween to enable separation of the distalmost suture locking clamp from the stack.
 10. The method of claim 1,wherein the cardiac implant is a prosthetic heart valve and the nativevalve annulus is the aortic annulus, and wherein there are three loopsof suture preinstalled at three locations around the aortic valveannulus, the three locations being aligned with the two coronary ostiaCO and the non-coronary sinus, and wherein the three suture loops arethe only sutures used to anchor the implant.
 11. A knotless method foranchoring a cardiac implant to a native valve annulus, the implanthaving been advanced to the native valve annulus down a plurality oflengths of suture that are preinstalled at the native valve annulus andthreaded through and around a periphery of the implant, the sutureshaving a thickness, the method comprising: providing an elongateddelivery tool having a delivery tube with a proximal end, a distal end,and a lumen therein; loading a plurality of axially stacked suturelocking clamps into the lumen of the elongated delivery tool, theelongated delivery tool having a pusher tube located within the deliverytube and in contact with a proximal most suture locking clamp; engaginga select one of the preinstalled lengths of suture with a distal mostsuture locking clamp positioned at the distal end of the delivery tube;advancing the distal end of the elongated delivery tool to the cardiacimplant; distally displacing the pusher tube so as to enable the distalmost suture locking clamp to clamp onto the select one of thepreinstalled lengths of suture; severing the select one of thepreinstalled lengths of suture clamped by the distal most suture lockingclamp; and sequentially repeating the steps of engaging, advancing,distally displacing and severing for a plurality of the suture lockingclamps around the periphery of the implant.
 12. The method of claim 11,wherein an actuator on the proximal end of the delivery tool iscalibrated to distally displace the pusher tube a distance equivalent toan axial height of one of the suture locking clamps with one actuation.13. The method of claim 11, wherein the delivery tool further includesan elongated retention member that extends through the lumen thereof andthrough each of the suture locking clamps, wherein each locking clamp isbiased to clamp onto the retention member, and wherein the delivery toolfurther includes an actuator on a proximal end thereof configured toboth retract the retention member relative to the stacked suture lockingclamps and to the pusher tube and distally displace the pusher tube. 14.The method of claim 13, wherein the actuator comprises a triggerconfigured to cause retraction of the retention member when pulled andthen distal displacement of both the pusher tube and the retentionmember when released, the method including actuating the trigger todeploy the distal most suture locking clamp onto the select one of thepreinstalled lengths of suture.
 15. The method of claim 11, wherein eachsuture locking clamp includes a pair of clamp halves each having aninner surface facing the inner surface of the other clamp half and abiasing member urging the inner surfaces of the clamp halves toward eachother, the delivery tool further having an elongated retention memberthat extends through and is imposed between the inner surfaces of theclamp halves of each suture locking clamp to maintain a slot in eachwide enough for the lengths of suture to pass through, and whereinretracting the retention member enables the biasing member to urge theinner surfaces of the clamp halves together and clamp onto the selectone of the preinstalled lengths of suture.
 16. The method of claim 15,wherein the elongated delivery tool has a longitudinal channelcommencing at the distal end and extending proximally along the deliverytube, and the step of engaging includes introducing the select one ofthe preinstalled lengths of suture into at least the slot of the distalmost suture locking clamp by passing the select one of the preinstalledlengths of suture radially inward through the longitudinal channel ofthe delivery tube.
 17. The method of claim 15, wherein each suturelocking clamp has a plurality of grip members on the inner surfaces ofthe clamp halves that are oriented to prevent relative longitudinalmovement between the suture locking clamp and the lengths of suture inonly one direction such that the suture locking clamp may be urgeddistally along the lengths of suture but not proximally, the methodincluding adjusting tension in the select one of the preinstalledlengths of suture clamped by the distal most suture locking clamp byurging the distal most suture locking clamp distally along the selectone of the preinstalled lengths of suture prior to the step of severing.18. The method of claim 11, wherein the delivery tube is formed of amanually malleable material to enable bending by a surgeon, and theretention member is flexible to avoid impeding bending of the deliverytube, the method including bending the delivery tube in conjunction withthe step of advancing.
 19. The method of claim 11, wherein the suturelocking clamps are bonded together in the stack with a weak pointtherebetween to enable separation of the distal most suture lockingclamp from the stack.
 20. The method of claim 11, wherein the cardiacimplant is a prosthetic heart valve and the native valve annulus is theaortic annulus, and wherein there are three loops of suture preinstalledat three locations around the aortic valve annulus, the three locationsbeing aligned with the two coronary ostia CO and the non-coronary sinus,and wherein the three suture loops are the only sutures used to anchorthe implant.